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InspireMD Announces Publication of 12-Month Results of CGuard EPS PARADIGM Trial in EuroIntervention Results indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained pro

Key Takeaway: Announces Publication of 12-Month Results of CGuard EPS PARADIGM Trial in EuroIntervention indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events Aviv, Israel - June 10, 20

Full Press Release Details

Announces Publication of 12-Month Results of CGuard EPS PARADIGM Trial in EuroIntervention
indicate that 12 months after carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against
postprocedural neurologic events
Aviv, Israel - June 10, 2020 - InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard Embolic Prevention
System (EPS) for the prevention of stroke caused by carotid artery disease treatment, announced today that 12-month PARADIGM trial
results have been published in the EuroIntervention journal. The paper, entitled, "Routine MicroNET covered
embolic prevention stent system use for consecutive symptomatic and increased stroke-risk asymptomatic carotid stenosis revascularization:
Twelve-month outcomes from the PARADIGM study," details the results of 101 unselected consecutive real-life patients treated
with the CGuard MicroNET covered stent for carotid stenosis and the 12-month prevention of postprocedural neurologic events.
unselected consecutive patients for carotid revascularization were enrolled in the PARADIGM trial. At 30 days, only one adverse
event occurred (a minor transient stroke with no other strokes, myocardial infarctions, or deaths. Furthermore, these study results
show that no strokes occurred between 30 days and twelve months.
evaluates CGuard in unselected consecutive patients for carotid revascularization, with higher clinical standards, and
constitutes a reference for future carotid stenting studies," said Marvin Slosman, Chief Executive Officer of InspireMD.
"This is substantiated by a new paper in EuroIntervention, a prestigious medical journal covering the latest advancements
in vascular intervention. The risk of peri-procedural or post-procedural stroke in the treatment of carotid stenotic lesions has
long been a significant obstacle to more widespread adoption of less invasive stenting as an alternative to surgery for carotid
revascularization. We believe these new data demonstrate the sustained safety of our unique CGuard EPS system incorporating
proprietary MicroNet technology. Data such as these are integral to our ongoing efforts to make CGuard the eventual
standard of care because of the many clinical benefits of CGuard .
present work indicates that an effective MicroNET -covered stent protection against post-procedural neurologic events extends
at least mid-term in the absence of any procedure- or device-related issues," stated Dr. Piotr Musialek, co-author of the
paper and lead investigator of the PARADIGM study.
is an international peer-reviewed journal whose aim is to create a community of high-quality research and education in the
field of percutaneous cardiovascular interventions. EuroIntervention is the official Journal of EuroPCR and the European
Association of Percutaneous Cardiovascular Interventions (EAPCI).
seeks to utilize its proprietary MicroNet technology to make its products the industry standard for the treatment
of carotid artery disease by providing outstanding acute results and durable stroke-free long-term outcomes.
common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American
under the ticker symbols NSPR.WS and NSPR.WSB.
press release contains "forward-looking statements." Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are
subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot
be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking
statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance
of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability
to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much
larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities
and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third
party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering
our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need
to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive
or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign
currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws
and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors
that may affect the realization of forward looking statements is set forth in the Company's filings with the Securities
and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov.
The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information,
future events or otherwise.
Last updated: Jun 10, 2020